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Anti-cancer agent

HIPEC during Surgery for Ovarian Cancer (HIPEC Trial)

Q: In what clinical situations is the combination of HIPEC and Carboplatin typically applied?

<p>Several types of <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>, including non-Hodgkin's <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a> and advanced <a href="https://www.withpower.com/clinical-trials/sarcoma">sarcoma</a> in their initial stages, can be treated using a combination of HIPEC chemotherapy and carboplatin.</p>

Phase 2

Recruiting

Led By Laurel Berry, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be without clinical evidence of disease including a negative exam, imaging (CT or PET/CT) and normal tumor markers (CA125) after completion of systemic chemotherapy

Cytoreductive surgery must result in an R-0, R-1 resection prior to systemic chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months post-treatment

Awards & highlights

HIPEC Trial Summary

This trial will test if it's possible to give chemotherapy directly into the abdomen during surgery, and if it has any effects on patients' health.

Who is the study for?

This trial is for adults over 18 with specific types of ovarian, fallopian tube, or peritoneal cancer. Participants must have completed certain surgeries and chemotherapy within a set timeframe, have no current evidence of disease, and meet specific health criteria like organ function. Pregnant individuals or those with recent infections, severe allergies to carboplatin, or unstable health conditions are excluded.Check my eligibility

What is being tested?

The study tests the feasibility and impact on quality of life when administering heated chemotherapy (HIPEC) during a second look laparoscopy surgery in patients who've had prior treatment for certain cancers. The FACT-O questionnaire will assess participants' quality of life outcomes.See study design

What are the potential side effects?

Potential side effects may include typical reactions to carboplatin such as nausea, fatigue, low blood counts leading to increased infection risk; pain or complications from surgery; and risks associated with heating the abdomen directly during HIPEC.

HIPEC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I show no signs of cancer after chemotherapy, confirmed by exams and tests.

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My surgery removed all visible cancer before starting chemotherapy.

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

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My cancer is in the ovary, fallopian tube, or peritoneum and is stage I-III or IVA with complete resolution after chemotherapy.

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My blood counts and liver/kidney functions are within normal ranges.

HIPEC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Patients To Succesfully Undergo Second Look Laparoscopy and Hyperthermic Intraperitoneal Chemotherapy

Secondary outcome measures

Number of Reported Toxicities

Quality of Life - Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire

HIPEC Trial Design

1Treatment groups

Experimental Treatment

Group I: Second Look Laparoscopy and HIPEC with CarboplatinExperimental Treatment3 Interventions

Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,242 Previous Clinical Trials

1,004,257 Total Patients Enrolled

5 Trials studying Ovarian Cancer

191 Patients Enrolled for Ovarian Cancer

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,844 Total Patients Enrolled

286 Trials studying Ovarian Cancer

73,766 Patients Enrolled for Ovarian Cancer

Laurel Berry, MDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Carboplatin (Anti-cancer agent) Clinical Trial Eligibility Overview. Trial Name: NCT04415944 — Phase 2

Ovarian Cancer Research Study Groups: Second Look Laparoscopy and HIPEC with Carboplatin

Ovarian Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04415944 — Phase 2

Carboplatin (Anti-cancer agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04415944 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination of HIPEC and Carboplatin been granted authorization by the FDA?

"The safety rating for HIPEC with Carboplatin is at a 2, as there exists evidence of the treatment's security but not its efficacy."

Answered by AI

How many volunteers are taking part in this trial?

"Absolutely. Per the information hosted on clinicaltrials.gov, this medical trial is presently recruiting patients for participation. It was initially posted in May 2021 and modified as recent October 2022; 10 participants are needed from 1 clinical centre."

Answered by AI

In what clinical situations is the combination of HIPEC and Carboplatin typically applied?

"Several types of cancer, including non-Hodgkin's lymphoma and advanced sarcoma in their initial stages, can be treated using a combination of HIPEC chemotherapy and carboplatin."

Answered by AI

Is enrollment open for this experiment?

"According to clinicaltrials.gov, this medical endeavour is currently looking for volunteers. It was initially published on May 20th 2021 and has been modified as recently as October 7th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy

2021. "Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04415944.

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